FDA-Clearance for HemoScreen Direct Capillary Sampling

This recent FDA clearance has finally brought HemoScreen to its full potential as a true POC hematology analyzer with its proprietary single-use reagent cartridge, automatic sample preparation, and exceptionally simple blood collection procedure.

FDA Clearance

HemoScreen has been FDA-cleared since 2018 as a moderately complex point-of-care hematology system, and is to date, the only 5-part diff CBC analyzer FDA-cleared for point-of-care use.
The initial 510K clearance (K180020) included both venous and capillary (fingerstick) testing as comparable performance was demonstrated between the two whole blood matrices (venous and capillary). In that initial validation, the capillary samples were collected from a fingertip puncture using a standard lancet, and blood was delivered into a standard K2EDTA microtube. Samples were then drawn from the microtube into the cartridge sampler to be tested by both the HemoScreen and the predicate test system (Sysmex). The use of the microtubes was an artifact of the clinical study as it was necessary to obtain a sufficiently large sample volume to enable testing in duplicate by both instruments.

However, the HemoScreen Sampler was specifically designed to facilitate direct capillary blood collection, which makes the procedure significantly more straightforward and more practical as compared to the use of a microtube. This recent FDA clearance adds the option of collecting the blood sample directly from the finger into a disposable that is part of the cartridge.

This enables the collection of a sample directly from the finger without an intermediate tube which is normally very difficult to fill without getting sample clotting. Direct sampling is a significant advantage over other blood count devices, as it enables unparalleled ease of capillary blood collection that does not require a phlebotomist or physician, requires much less expertise, is quicker, painless, and is much less prone to pre-analytical errors.